Scientific Substantiation

Companies often need guidance to determine whether their advertising content is adequately supported by competent and reliable scientific evidence. When it is not, product sponsors often require help revising their copy to better align with the evidence and to ensure that they are making well-substantiated marketing claims. When marketing copy is not adequately supported, it can result in serious consequences, including regulatory action by the Food and Drug Administration (FDA) or the Federal Trade Commission (FTC). Lumanity can be your trusted partner in product stewardship.

Tension often arises between the desire to promote product benefits and what the science demonstrates. No matter how good the science may be, if it does not align with the claim or is not consistent with the totality of evidence, then claim is not substantiated. Lumanity provides guidance as to when marketing content is adequately substantiated based on “competent and reliable” science evidence. When it is not, we assist clients to revise their marketing claims to better align with the science.

We develop rigorous claim substantiation assessment reports that help our clients ensure marketing content is well-supported by “competent and reliable” scientific evidence.

We carefully review the available scientific evidence to ensure that marketing claims have the following important characteristics:

• scientifically sound
• relevant to the specific product and desired claim
• appropriate for the intended consumer and use being promoted
• aligned with the totality of evidence
• regulatory compliant